Moderate or Severe Nasolabial FoldsNCT06509477

Effectiveness and Safety Comparison of Lunaphil Ultra (Hyaluronic Acid, by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, by Allergan Co.) in Nasolabial Folds (NLFs) Management

A study testing Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.) and Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.) in people with Moderate or Severe Nasolabial Folds, run by Espad Pharmed at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Moderate or Severe Nasolabial Folds
What is being tested?: Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.) and Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteIran
Study dates: 1 Dec 2021to 11 Nov 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects ≥ 30 years of age
Visible bilateral NLFs that were approximately symmetrical and had an equal severity ranging from moderate to severe (assessed at the deepest part)
Able to follow study instructions and likely to complete all required visits
Signed informed consent

Who cannot join

History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs
Acute herpetic eruption
Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
Known sensitivity to local anesthetics of the amide type (such as lidocaine), history of hypersensitivity to gram-positive bacterial proteins, history of multiple severe allergies, history of anaphylactic shock
Known hypersensitivity to any component of the study products or excipients (like hyaluronic acid)
History of receiving immune therapy or a history of autoimmune disease

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History of active chronic debilitating systemic disease
History of connective tissue disease, history of malignancy (except for non-melanoma skin cancer) within the last 5 years
Clinically significant active dermatologic disorders within the last 6 months
Use of oral retinoids, over-the-counter (OTC) or prescription antiwrinkle treatments, microdermabrasion, or chemical peels in the NLF area within the last 4 weeks or intention to use them during the study
Any prior cosmetic procedure or tissue augmentation at the NLF injection site within 1 year before study entry (or intent to undergo such a procedure during the study)
Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Iran1 site

Orchid Pharmed, Medical Department
Tehran, 19947-66411

Other trials in Iran

About this study

Official title: A Randomized, Double-masked, Active Controlled, Within-subject Equivalency Clinical Trial to Compare Effectiveness and Safety of Lunaphil Ultra (Hyaluronic Acid, Produced by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, Produced by Allergan Co.) for the Management of Moderate or Severe Nasolabial Folds

Rationale and background: Skin aging is a complex process that results in various changes in the skin, including wrinkles, sun spots, and sagging skin. The NLF is a natural change that becomes more prominent with aging and significantly affects the beauty of the facial skin. Dermal fillers, particularly hyaluronic acid (HA) fillers, are commonly used to correct these signs of aging. This study aimed to compare the effectiveness and safety of Lunaphil Ultra with Juvederm Ultra 4® for treating NLFs.

Primary objective: Effectiveness assessment of Lunaphil Ultra Secondary objectives: Effectiveness and safety assessment of Lunaphil Ultra Study design: This is a randomized, double-masked, active controlled, within-subject, and equivalency clinical trial.

Setting: Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.

Conditions: Moderate or Severe Nasolabial Folds
Being tested: Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.), Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)
Medical subject headings: Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)Device
Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion
Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)Device
Two treatments will be allowed over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs based on investigator's opinion

Study groups in NCT06509477
Study group	Role	What they receive
Lunaphil Ultra (by Espad Pharmed Co.)	Experimental	Lunaphil Ultra (by Espad Pharmed Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s). Receives: Device: Hyaluronic acid Lunaphil Ultra (by Espad Pharmed Co.)
Juvederm Ultra 4® (by Allergan Co.)	Active comparator	Juvederm Ultra 4® (by Allergan Co.) will be administered over a 2-week period (initial treatment plus one touch-up) to achieve optimal correction of the NLFs. In case of suboptimal correction of NLFs at week 2 after the initial treatment, the treating investigator will be directed to retreat the under corrected NLF(s). Receives: Device: Hyaluronic acid Juvederm Ultra 4® (by Allergan Co.)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Level of Improvement From Baseline in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)
The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds
Measured: 24 weeks

Secondary outcomes (5)

Number of Subjects With an Improved Score From Baseline Based on Physician Global Aesthetic Improvement Scale (PGAIS)
The scores are from 1 to 5, 1 indicating exceptional improvement and 5 indicating worsened results
Measured: 24 weeks
Number of NLFs Maintaining a Clinically Significant Improvement in NLF Severity Score by Wrinkle Severity Rating Scale (WSRS)
≥1-point reduction from baseline. The scores are from 1 to 5, 1 indicating no visible folds and 5 indicating extreme folds
Measured: 24 weeks
The Injected Volume to Obtain Optimal Aesthetic Result
initial treatment + touch-up
Measured: 2 weeks
The Number of NLFs Receiving Touch-up Treatment
Counting the number of NLF who need additional injection
Measured: 2 weeks
Evaluation of Adverse Events During 24 Weeks
All reported AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA) terms and are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202111 Nov 2023

First posted19 Jul 2024
Study start1 Dec 2021
Primary completion11 Nov 2023
Study completion11 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Moderate or Severe Nasolabial FoldsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a randomized, double-masked, active controlled, within-subject, paired, and equivalency clinical trial. Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06509477
Sponsor's protocol ID: LUN.ESP.KB.IV.00
Status last verified: Jan 2026
First submitted: 8 Jul 2024
Last updated: 3 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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